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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device processor, tissue, automated
Regulation Description Automated tissue processor.
Product CodeIEO
Regulation Number 864.3875
Device Class 1

Device Problems
No Known Device Problem 175
Improper or incorrect procedure or method 133
Use of Device Issue 35
No code available 23
Device operates differently than expected 12
Device displays error message 8
Failure to cycle 7
Mechanical issue 4
Leak 3
Device handling issue 3
Device maintenance issue 2
Fluid leak 2
No Information 2
Product quality issue 1
Unknown (for use when the device problem is not known) 1
Therapeutic or diagnostic output failure 1
Not Applicable 1
Human-Device Interface Issue 1
Maintenance does not comply to manufacturers recommendations 1
Total Device Problems 415

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 2 1 1 1 0 1 0 1
Class III 0 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jul-03-2017
2 Leica Microsystems, Inc. II Sep-22-2015
3 Leica Microsystems, Inc. III Sep-17-2015
4 Leica Microsystems, Inc. II Jul-29-2013
5 Leica Microsystems, Inc. II Apr-27-2012
6 Leica Microsystems, Inc. II Jun-20-2011
7 Leica Microsystems, Inc. II May-07-2010
8 Thermo Fisher Scientific II Apr-12-2010

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